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- Title
PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs: approval of nivolumab for unresectable advanced or recurrent epithelial skin malignancies in Japan.
- Authors
Matsumura, Noriomi; Mandai, Masaki
- Abstract
The article discusses the approval of the anticancer drug nivolumab in Japan for the treatment of unresectable advanced or recurrent epithelial skin malignancies. The drug is an anti-human PD-1 monoclonal antibody and was evaluated in a trial with 31 patients, achieving a response rate of 19.4%. The safety profile of nivolumab was consistent with previous clinical trials. Additionally, the article mentions revisions to the precautions for other anticancer drugs based on post-marketing safety assessments.
- Subjects
JAPAN; DRUG approval; ANTINEOPLASTIC agents; NIVOLUMAB; REGULATORY approval
- Publication
International Journal of Clinical Oncology, 2024, Vol 29, Issue 6, p639
- ISSN
1341-9625
- Publication type
Article
- DOI
10.1007/s10147-024-02524-0